Guidance

2 The procedure

2 The procedure

2.1 Indications

2.1.1 Sacral nerve stimulation is used to treat the symptoms of an overactive bladder, including urinary urge incontinence and/or urgency frequency in patients who have failed or cannot tolerate conventional treatments.

2.1.2 In patients for whom conservative treatments have been unsuccessful, the standard alternatives include bladder reconstruction (such as augmentation and cystoplasty) and urinary diversion.

2.2 Outline of the procedure

2.2.1 Sacral nerve stimulation involves applying an electric current to one of the sacral nerves via an electrode placed through the corresponding sacral foramen. The electrode leads are attached to an implantable pulse generator, which stimulates nerves associated with the lower urinary tract.

2.3 Efficacy

2.3.1 This procedure was subject to a systematic review commissioned by the Institute in November 2003. Evidence from two randomised controlled trials (RCTs), including a total of 50 patients with urge incontinence, showed that complete continence (completely dry with no incontinent episodes) or improvement of more than 50% in incontinence symptoms was observed in 50% and 80% of patients, respectively, following the procedure. This compared with 5% of patients in the control groups, who were receiving conservative treatments while waiting for an implant. In the one RCT that reported on patients with urgency-frequency, an improvement of more than 50% in incontinence symptoms was observed in 56% (14/25) of patients, compared with 4% (1/25) in the control group. More evidence is available for patients with urge incontinence than for those with urgency-frequency. For more details, refer to the Sources of evidence section.

2.3.2 The results of the case series studies included in the systematic review showed similar results, with complete continence and improvement in symptoms being reported in 39% (139/361) and 67% (338/501) of patients with urge incontinence, respectively, and 41% (22/54) and 65% (75/116) of patients with urgency-frequency, respectively. The benefits of sacral nerve stimulation were reported to persist for at least 3–5 years after implantation. For more details, refer to the Sources of evidence section.

2.4 Safety

2.4.1 In general, evidence on the safety of this procedure was not well reported. Most complications observed in the studies were the result of technical problems related to implantation of the device. The results of the systematic review showed that, overall, the re-operation rate for patients with implants was 33% (283/860). The most common reasons for surgical revision were to replace or reposition implants due to pain or infection at the implant site, or to adjust and modify the lead system to correct breakage or migration. For more details, refer to the Sources of evidence section.

2.4.2 Pain at the site of the pulse generator or at the site of stimulation was reported in 24% (162/663) of patients, sometimes requiring replacement and repositioning of the pulse generator. Other complications included lead-related problems such as migration (16%), wound problems (7%), adverse effects on bowel function (6%), and infection (5%). No cases of long-lasting neurological complications were identified. For more details, refer to the Sources of evidence section.

2.5 Other comments

2.5.1 There is a lack of long-term quality of life data.

2.5.2 There is limited evidence relating to the use of this procedure in older patients.